{"description":"Eleven ineligible patients are not reported in the adverse events.","eventGroups":[{"description":"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.\n\netanercept: Given IV and subcutaneously\n\nmethylprednisolone: Given IV and orally","id":"EG000","otherNumAffected":6,"otherNumAtRisk":28,"seriousNumAffected":5,"seriousNumAtRisk":28,"title":"Etanercept and Corticosteroid Therapy"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Acute kidney injury"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Ascites"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Creatinine increased"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Enterocolitis infectious"},{"organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Hepatic failure"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Hypokalemia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Infections and infestations - Other, specify"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Neutrophil count decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Platelet count decreased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Pneumothorax"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":28}],"term":"White blood cell decreased"}],"seriousEvents":[{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Acute kidney injury"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Adult respiratory distress syndrome"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Alkalosis"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Blood bilirubin increased"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Death NOS"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Esophageal hemorrhage"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Hyperglycemia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":28}],"term":"Hypoxia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Infections and infestations - Other, specify"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Multi-organ failure"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Nervous system disorders - Other, specify"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Peripheral motor neuropathy"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Pleural effusion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Pneumonitis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Pneumothorax"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Upper respiratory infection"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28}],"term":"Ventricular arrhythmia"}]}